Outcome Measures In Rheumatoid Arthritis Clinical Trials Research Articles

Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial

PurposeThe purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA). Materials and methodsThis prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0–100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria. ResultsTwenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function. ConclusionGAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months.

Salivary gland ultrasound is associated with the presence of autoantibodies in patients with Sjögren's syndrome: A Danish single-centre study.

To investigate whether ultrasound findings of major salivary glands are correlated with serological markers, autoantibodies, patient- or doctor-reported disease activity in a Danish cohort of patients with primary Sjögren's Syndrome (pSS). In all, 49 patients at Odense University Hospital with pSS diagnosed according to the 2002 American-European Consensus Group (AECG) classification criteria were included. Patients were characterized using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI, score of systemic complications) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), serologic markers, Schirmer's test and salivary test. Salivary gland ultrasound (SGUS) was performed of the submandibular and parotid glands and scored according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) semi-quantitative scoring system. More patients with abnormal SGUS had antinuclear antibodies (ANA) (p = 0.002), anti-Ro52 (p = 0.001), anti-Ro60 (p<0.001), anti-La (p<0.001) and IgM-RF (p<0.001). Titers for ANA (p = 0.02) and anti-Ro52 (p = 0.03) were higher in patients with abnormal SGUS. Twenty-three of the pSS patients had no pathological findings on SGUS. There was no correlation between SGUS severity and ESSDAI- or ESSPRI-scores. Abnormal SGUS findings are associated with autoantibodies of high specificity for pSS but not with ESSDAI, ESSPRI or inflammatory markers.

Safety, tolerability, and efficacy of pirfenidone in patients with rheumatoid arthritis-associated interstitial lung disease: a randomised, double-blind, placebo-controlled, phase 2 study

Interstitial lung disease is a known complication of rheumatoid arthritis, with a lifetime risk of developing the disease in any individual of 7·7%. We aimed to assess the safety, tolerability, and efficacy of pirfenidone for the treatment of patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). TRAIL1 was a randomised, double-blind, placebo-controlled, phase 2 trial done in 34 academic centres specialising in interstitial lung disease in four countries (the UK, the USA, Australia, and Canada). Adults aged 18-85 years were eligible for inclusion if they met the 2010 American College of Rheumatology and European Alliance of Associations for Rheumatology criteria for rheumatoid arthritis and had interstitial lung disease on a high-resolution CT scan imaging and, when available, lung biopsy. Exclusion criteria include smoking, clinical history of other known causes of interstitial lung disease, and coexistant clinically significant COPD or asthma. Patients were randomly assigned (1:1) to receive 2403 mg oral pirfenidone (pirfenidone group) or placebo (placebo group) daily. The primary endpoint was the incidence of the composite endpoint of a decline from baseline in percent predicted forced vital capacity (FVC%) of 10% or more or death during the 52-week treatment period assessed in the intention-to-treat population. Key secondary endpoints included change in absolute and FVC% over 52 weeks, the proportion of patients with a decline in FVC% of 10% or more, and the frequency of progression as defined by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02808871. From May 15, 2017, to March 31, 2020, 231 patients were assessed for inclusion, of whom 123 patients were randomly assigned (63 [51%] to the pirfenidone group and 60 [49%] to the placebo group). The trial was stopped early (March 31, 2020) due to slow recruitment and the COVID-19 pandemic. The difference in the proportion of patients who met the composite primary endpoint (decline in FVC% from baseline of 10% or more or death) between the two groups was not significant (seven [11%] of 63 patients in the pirfenidone group vs nine [15%] of 60 patients in the placebo group; OR 0·67 [95% CI 0·22 to 2·03]; p=0·48). Compared with the placebo group, patients in the pirfenidone group had a slower rate of decline in lung function, measured by estimated annual change in absolute FVC (-66 vs -146; p=0·0082) and FVC% (-1·02 vs -3·21; p=0·0028). The groups were similar with regards to the decline in FVC% by 10% or more (five [8%] participants in the pirfenidone group vs seven [12%] in the placebo group; OR 0·52 [95% CI 0·14-1·90]; p=0·32) and the frequency of progression as defined by OMERACT (16 [25%] in the pirfenidone group vs 19 [32%] in the placebo group; OR 0·68 [0·30-1·54]; p=0·35). There was no significant difference in the rate of treatment-emergent serious adverse events between the two groups, and there were no treatment-related deaths. Due to early termination of the study and underpowering, the results should be interpreted with caution. Despite not meeting the composite primary endpoint, pirfenidone slowed the rate of decline of FVC over time in patients with RA-ILD. Safety in patients with RA-ILD was similar to that seen in other pirfenidone trials. Genentech.

Development of a core outcome set for the orthopaedic management of spinal dysraphism : a study protocol.

AimsThe aim of this study is to define a core outcome set (COS) to allow consistency in outcome reporting amongst studies investigating the management of orthopaedic treatment in children with spinal dysraphism (SD).MethodsRelevant outcomes will be identified in a four-stage process from both the literature and key stakeholders (patients, their families, and clinical professionals). Previous outcomes used in clinical studies will be identified through a systematic review of the literature, and each outcome will be assigned to one of the five core areas, defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). Additional possible outcomes will be identified through consultation with patients affected by SD and their families.ResultsOutcomes identified in these stages will be included in a two-round Delphi process that will involve key stakeholders in the management of SD. A final list including the identified outcomes will then be summarized in a consensus meeting attended by representatives of the key stakeholders groups.ConclusionThe best approach to provision of orthopaedic care in patients with SD is yet to be decided. The reporting of different outcomes to define success among studies, often based on personal preferences and local culture, has made it difficult to compare the effect of treatments for this condition. The development of a COS for orthopaedic management in SD will enable meaningful reporting and facilitate comparisons in future clinical trials, thereby assisting complex decision-making in the clinical management of these children.Cite this article: Bone Jt Open 2022;3(1):54–60.

P144 What is the role of musculoskeletal ultrasound in assessing disease activity of RA in pregnancy?

Abstract Background/Aims In rheumatoid arthritis (RA), musculoskeletal ultrasound (MSK-US) has greater sensitivity for the detection of active disease than clinical assessment using the DAS28 score, which is prone to false elevation by a spuriously high tender joint count (TJC) and/or visual analogue score (VAS) from non-RA causes. Thus, DAS28 may correlate poorly with MSK-US findings. In pregnancy, standardised disease activity of RA comprises calculation of the modified DAS28(3)CRP score, with removal of the VAS and ESR, both of which are confounded by pregnancy, and replacement with CRP; however, it is unknown whether non-specific musculoskeletal pain and/or peripheral oedema in (especially late) pregnancy might contribute to the TJC or swollen joint count (SJC) respectively and thus render this adapted score less reliable. Therefore, we conducted this study of pregnant RA patients and controls to assess the ability of the DAS28(3)CRP to detect disease activity compared with MSK-US. Methods Pregnant RA patients were recruited from the UCLH obstetric rheumatology clinic from September 2018 to March 2020. Patients underwent clinical assessment with DAS28(3)CRP and MSK-US longitudinally through pregnancy/post-partum. A control group of age-matched non-pregnant female RA patients was recruited from general rheumatology clinics and had equivalent assessments. MSK-US was undertaken using a Logiq S8. The standard protocol comprised 22-joint assessment of hands (dorsal longitudinal and transverse views of wrists, metacarpophalangeal and proximal interphalangeal joints). Quantification of Power Doppler (PD) signal was made as per the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) US definitions. PD scores were calculated as mean scores of all joints scanned. Statistical correlations were performed in SPSS using Spearman’s rank coefficient as data were non-normally distributed. Results A total of 45 MSK-US scans of pregnant/postpartum RA patients (N = 24, mean age 34.5+-3.6) were performed and compared to a control group of non-pregnant RA patients, who were scanned once each (N = 18, mean age 32.3+-5.2; p = 0.12). In the second (T2) and third trimester (T3) and the postpartum (PP), there was a significant positive correlation between DAS28(3)CRP and PD score (T2, ρ = 0.87 (p &amp;lt; 0.01); T3, ρ = 0.76 (p &amp;lt; 0.01); PP, ρ = 0.68 (p = 0.03)). Interestingly, each of these were stronger correlations than the equivalent comparison in non-pregnant RA patients (ρ = 0.51 (p = 0.03)). TJC also significantly positively correlated with PD score in each trimester of pregnancy and postpartum, but not in non-pregnant patients; difference between correlation coefficients was statistically significant for each trimester (T1, p &amp;lt; 0.01; T2, p = 0.05; T3, p = 0.05). Conclusion Interestingly, we found that that DAS28(3)CRP correlates better with PD signal on MSK-US in pregnancy than in non-pregnancy. Specifically, there was significantly better correlation of the TJC with PD score. It is unclear why non-inflammatory contributors to the TJC may be less prominent in pregnancy and further investigation is warranted. Disclosure C. Raine: Grants/research support; C.R. has received research funding from UCB. J. Manson: None. C. Ciurtin: None. I. Giles: Grants/research support; IG has received an unrestricted educational grant, speaker's fees and travel fees from UCB.

Sleep Disturbances are a Significant Predictor of Chikungunya Arthritis Flare Severity.

Objective:The primary objective of this research was to explore the link between sleep and flare pain associated with chikungunya virus (CHIKV) infection. The secondary objective was to investigate if cytokines and T regulatory (Treg) cells have an influence on this relationship.Methods:A cross-sectional study was performed using data collected in Barranquilla, Colombia, which enrolled patients with and without chronic arthritis with a history of chikungunya infection. Flare severity was measured by a version of the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) flare questionnaire adapted for CHIKV arthritis, including metrics for pain, difficulty with physical activity, fatigue, stiffness and difficulty maintaining social activities due to arthritis that contribute to flare severity. In addition, four sleep disturbance items, five inflammatory cytokine levels, four anti-inflammatory cytokine levels, and six Treg levels were measured. Then, multivariable linear regression models were used to test the direct and indirect effects of flare-pain on sleep disturbance, and to determine whether this relationship was mediated by cytokines or Tregs. Finally, the SAS CALIS procedure was used to test path models showing possible causal effects with mediators and confounds.Results:The analysis showed that sleep disturbance is positively correlated with CHIKV arthritis flare pain, and that it is a significant predictor of flare severity after adjusting for demographic variables, cytokine, and T cell levels. Further, neither T cells nor cytokines mediate the pain/sleep relationship in CHIKV arthritis.Conclusion:There is a strong association between sleep disturbance and arthritis flare pain and severity; however, this relationship is not mediated by cytokines or T cells. Since this study is unable to determine causation, further research is needed to determine the mechanism underlying the relationship between sleep disturbances and CHIKV arthritis flares.

EP31 Musculoskeletal ultrasound of rheumatoid arthritis pregnancy: a single centre experience

Abstract Background The utility of musculoskeletal ultrasound (MSK-US) in the measurement of disease activity of rheumatoid arthritis (RA) is well established. However, it has not been formally studied in pregnancy, with the literature limited to a single case report. Standard disease activity assessment in RA pregnancy comprises measurement of the DAS28(3) CRP score, which removes the visual analogue score (VAS) and replaces ESR with CRP, as both of these components may be confounded by pregnancy. Use of this modified score remains problematic as the tender joint count may be affected by non-specific musculoskeletal pain in pregnancy, and the swollen joint count may be obscured by peripheral oedema, especially late in pregnancy. No study of RA in pregnancy has used MSK-US to measure disease activity. Our objective was to conduct a pilot study of MSK-US in RA pregnancy, and compare findings with clinical assessment using the DAS28(3)CRP score. Methods We offered MSK-US to pregnant RA patients attending the UCLH obstetric rheumatology clinic from September 2018 to September 2019. Patients were assessed longitudinally through pregnancy/post-partum where possible. Examination was undertaken using a Logiq S8 US machine. The standard protocol comprised 22-joint assessment of hands (dorsal longitudinal and transverse views of wrists, metacarpophalangeal and proximal interphalangeal joints). In the feet, bilateral MTP joints were scanned with longitudinal views. Quantification of Power Doppler (PD) signal and grey scale (GS) synovitis was made as per the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) US definitions. PD and GS scores were calculated as mean scores of all joints scanned. Results To date, 17 pregnant RA patients have undergone a total of 35 MSK-US studies. Disease activity assessments showed 10/17 patients with persistent low activity through pregnancy, 5/17 with moderate or good response, 1/17 with no response and 1/17 with a moderate flare. Overall, PD scores correlated well with DAS28(3) CRP assessment (R2 = 0.68). All patients at moderate or high disease activity by DAS28(3) CRP had ≥1 joint with detectable PD signal, but 2/21 patients clinically in ‘remission’ and 3/7 patients in ‘low disease activity’ had detectable PD. One patient with only 2 tender and 1 swollen joints (and normal CRP; DAS28 3.17) had very extensive PD signal and contributed to the decision to recommence anti-TNF treatment in the 3rd trimester. It was noted that increased vascularity in pregnancy can complicate the assessment of synovial PD signal. MSK-US was particularly helpful in distinguishing true joint synovitis from subcutaneous oedema in the feet. Conclusion This is the first series of MSK-US in pregnant RA patients. The detection of active joint synovitis (by PD signal) in clinical remission/low disease activity states suggests a potential role for MSK-US in confirming apparent low disease activity in pregnancy, and thus guiding stratification of treatment. Disclosures C. Raine None. J. Manson None. C. Ciurtin None. I. Giles None.

High-resolution MRI of flexor tendon pulleys using a 16-channel hand coil: disease detection and differentiation of psoriatic and rheumatoid arthritis

BackgroundTo evaluate the value of 3 Tesla (T) magnetic resonance imaging (MRI) changes of flexor tendon pulleys for the differentiation of psoriatic (PsA) and rheumatoid arthritis (RA), using a novel 16-channel high-resolution hand coil.MethodsSeventeen patients with active PsA, 20 patients with active RA, and 16 healthy controls (HC) underwent high-resolution 3 T MRI using the dedicated 16-channel hand coil. Images were analyzed by three independent readers for the degree of inflammatory changes, thickness of flexor tendon pulleys, and comparison to the outcome measures for RA clinical trials (OMERACT) PsA MRI score (PsAMRIS) and to its sub-scores. For correlation analyses, Spearman rho correlation was calculated.ResultsFlexor tendon pulleys were thicker in PsA than in RA patients (mean difference 0.16 mm, p < 0.001) and HC (mean difference 0.2 mm, p < 0.001) and showed a higher degree of associated inflammatory changes (mean difference from RA 4.7, p = 0.048; mean difference from HC 14.65, p < 0.001). Additionally, there was a strong correlation of accessory pulley inflammation and PsAMRIS and its acute-inflammatory sub-scores, flexor tenosynovitis, synovitis, and periarticular inflammation (for the second digit synovitis ρ = 0.72, flexor tenosynovitis ρ = 0.7, overall PsAMRIS ρ = 0.72, p < 0.01). Similar robust correlations were evident in digits 3–5. Weaker correlations were evident in RA (synovitis ρ = 0.49, flexor tenosynovitis ρ = 0.49, periarticular inflammation ρ = 0.4).ConclusionThe assessment of MRI changes of flexor tendon pulleys is potentially beneficial for disease detection in PsA, as well as for its distinction from RA and HC.Trial registration2014123117, December 2014.

Key Challenges in Rheumatic and Musculoskeletal Disease Translational Research

Biotherapeutics have greatly advanced the world of medicine, and products such as monoclonal antibodies, fusion proteins and receptor antagonists have transformed the therapeutic armamentarium for rheumatic and musculoskeletal diseases (RMD) in the last 20 years. Biological understanding of a disease can result in novel targeted therapeutics, whereas new molecular pathological insights can stem from observations when patients have responded differently to the same treatment. Rheumatoid arthritis (RA) provides an excellent example of the bidirectional nature of translational research involving clinicians and scientists working in concert with mutual understanding of both the clinical problem and the scientific solution. RA biotherapeutics are effective in many but not all patients, and adverse effects, namely increased infections, may limit their use. The current challenges for translational research and biomedicine in RMD/RA therefore focus on the following issues: (i) early diagnosis, (ii) personalised medicine, and (iii) assessment of outcome. The unifying theme to these challenges is the development of biomarkers, as will be evidenced in the next paragraphs. There have been significant advances in relation to early diagnosis for RMD over the past 10 years. Clinical awareness and the importance of an early diagnosis were increased from 1991 with the growth of early arthritis clinics and the application of the 1987 diagnostic criteria for RA. These classification criteria were updated in 2010 with significant changes. A new biomarker for RA – anti-citrullinated antibody (anti-CCP) – was first suggested when citrulline was described as an essential antigenic constituent of RA-specific antibodies (Schellekens et al., 1998). Anti-CCP antibodies only became widely available commercially as recently as 2007, and since this time their utility has been expanded to include both diagnostic and prognostic markers of RA, as they are recognised to be associated with poor prognosis or outcome as well as diagnosis (De Rycke et al., 2004). Even more recently, the presence of anti-CCP and rheumatoid factor antibodies has been described in some subjects year before they develop the signs or symptoms of the disease (Rantapaa-Dahlqvist et al., 2003). This knowledge has led to a number of strategic studies exploring treatment options for very early RA, at a stage that subjects with joint symptoms and positive antibodies may receive therapy before signs of RA develop. The full implications of these studies are awaited (Gerlag, 2013). The concept of personalised medicine is not new, however the rapid advances in technologies such as genomics, transcriptomics and metabolomics for the analysis of blood and tissue has opened up new horizons in this area in the last few years (Isaacs and Ferraccioli, 2011). As outlined above, the range of biotherapeutics now available for the treatment of RMD is extensive, and the key challenge for translational scientists is to create and validate a strategic approach to the treatment of RA (Ma et al., 2014). Early diagnosis is only the first step, subsets of patients need to be stratified by a reliable biomarker, or more likely a combination of biomarkers, that will allow treatment decisions to follow an algorithm defined on a pathological basis, similar to that which has been developed for the treatment of breast cancer (Perou et al., 2000). For example, it has been suggested that B-lymphocyte infiltrates on immunohistochemistry of synovial tissue may be a biomarker of response to therapy with rituximab in RA patients. In order to gauge the success or failure of treatments in RMD, following early diagnosis and strategic patient stratification, we need reliable and feasible outcome measures. A multidisciplinary group of researchers have attempted to refine and develop Outcome MEasures in Rheumatoid Arthritis Clinical Trials (OMERACT) using a progressive and well-defined methodology, combining literature review and consensus over the past 20 years (Kirkham et al., 2013). Initially, the focus of the group was on RA alone; however over time, they have extended this approach to most RMD and included clinicians, nurses, industry partners and, possibly most importantly, the patients themselves. This group was the first to identify and validate a synovial tissue biomarker – CD68 – to reflect synovial pathologic responses in clinical trials (Smith et al., 2006). It may be relatively easy to define the patient who achieves complete remission – no clinical signs or symptoms of disease activity and no residual damage – but this is unfortunately quite rare. According to the most recent studies examining the new EULAR/ACR remission criteria, complete remission may apply to only 10% or less of treated patients (Balogh et al., 2013). In conclusion, there are significant challenges ahead for clinicians and scientists engaged in translational research in RMD, and specifically in RA. There is, however, significant potential for advances to be made, in particular using modern technologies applied to blood and synovial tissue samples in subjects with well-defined clinical characteristics combined in a systems biology analysis.

MRI osteitis predicts cartilage damage at the wrist in RA: a three-year prospective 3T MRI study examining cartilage damage

IntroductionCartilage damage impacts on patient disability in rheumatoid arthritis (RA). The aims of this magnetic resonance imaging (MRI) study were to investigate cartilage damage over three years and determine predictive factors.MethodsA total of 38 RA patients and 22 controls were enrolled at t = 0 (2009). After 3 years, clinical and MRI data were available in 28 patients and 15 controls. 3T MRI scans were scored for cartilage damage, bone erosion, synovitis and osteitis. A model was developed to predict cartilage damage from baseline parameters.ResultsInter-reader reliability for the Auckland MRI cartilage score (AMRICS) was high for status scores; intraclass correlation coefficient (ICC), 0.90 (0.81 to 0.95) and moderate for change scores (ICC 0.58 (0.24 to 0.77)). AMRICS scores correlated with the Outcome MEasures in Rheumatoid Arthritis Clinical Trials (OMERACT) MRI joint space narrowing (jsn) and X-Ray (XR) jsn scores (r =0.96, P < 0.0001 and 0.80, P < 0.0001, respectively). AMRICS change scores were greater for RA patients than controls (P = 0.06 and P = 0.04 for the two readers). Using linear regression, baseline MRI cartilage, synovitis and osteitis scores predicted the three-year AMRICS (R2 = 0.67, 0.37 and 0.39, respectively). A multiple linear regression model predicted the three-year AMRICS (R2 = 0.78). Baseline radial osteitis predicted increased cartilage scores at the radiolunate and radioscaphoid joints, P = 0.0001 and 0.0012, respectively and synovitis at radioulnar, radiocarpal and intercarpal-carpometacarpal joints also influenced three-year cartilage scores (P-values of 0.001, 0.04 and 0.01, respectively).ConclusionsMRI cartilage damage progression is preceded by osteitis and synovitis but is most influenced by pre-existing cartilage damage suggesting primacy of the cartilage damage pathway in certain patients.

Does enthesopathy relate to M694V gene mutation in patients with Familial Mediterranean fever?

Familial Mediterranean fever (FMF) is a systemic hereditary autoinflammatory disorder. The present study aimed to investigate the relationship of enthesitis to FMF and to search the potential association between enthesitis and MEFV gene missense variations in patients with FMF. The study consisted of 72 FMF patients (mean age 29.12 ± 11.47 years, 32 females), 29 patients with ankylosing spondylitis (AS) (mean age 34.14 ± 11.73 years, 16 females), and 34 healthy volunteers (mean age 23.06 ± 6.41 years, 8 females). FMF patients were classified according to the kind of MEFV gene mutation. Doppler ultrasound was used to determine enthesitis based on the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) scoring system. OMERACT score was significantly different between FMF patients and control group (p < 0.001 in all patients, p = 0.009 in men, and p = 0.002 in women). However, it was not significantly different between FMF and AS patients in both sexes. OMERACT score did not differ between FMF patients with and without M694V gene mutation. The best cutoff point of OMERACT score to predict enthesitis was found as ≥0.5 with sensitivity of 29 %, specificity of 100 %, positive predictive value of 100 %, and negative predictive value of 40 %.

Outcome Measures in Psoriasis and Psoriatic Arthritis

The recent health policy imperatives in the United States have consequentially called to attention the absence of dermatologic evaluations in the health outcome and quality measures that will ultimately grade the success of providers. Psoriasis, in particular, represents a patient cohort with a chronic, complex and debilitating skin disorder commonly encountered in dermatology clinics that can have insufferable consequences from disease progression and comorbidities if it is not properly evaluated and managed. In order to have the appropriate compensation to the providers and the availabilities of the correct treatments to the patients, the presence of psoriasis-specific outcome measures are necessary. Incorporating the concepts employed by the rheumatology group, Outcome Measures for Rheumatoid Arthritis Clinical Trials (OMERACT), that created outcomes for several musculoskeletal diseases, initiatives in dermatology have already begun to create standardized, validated psoriasis outcome measures.

Iterative decomposition of water and fat with echo asymmetry and least‐squares estimation (IDEAL) of the wrist and finger at 3T: Comparison with chemical shift selective fat suppression images

To compare fat-suppressed magnetic resonance imaging (MRI) quality using iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL) with that using chemical shift selective fat-suppressed T1-weighted spin-echo (CHESS) images for evaluating rheumatoid arthritis (RA) lesions of the hand and finger at 3T. MRI was performed in eight healthy volunteers and eight RA patients with a 3.0T MR system (Signa HDxt GE healthcare) using an eight-channel knee coil. FS-CHESS-T1-SE and IDEAL imaging were acquired in the coronal planes covering the entire structure of the bilateral hands with a slice thickness of 2 mm. In the RA patients both images were obtained after intravenous gadolinium administration. Image quality was evaluated on a five-point scale (1 = excellent to 5 = very poor). Synovitis and bone marrow contrast uptake on MR images were reviewed by two musculoskeletal radiologists using the Rheumatoid Arthritis MRI Scoring System (RAMRIS) of the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) group. IDEAL showed uniform FS unaffected by magnetic field inhomogeneity and challenging geometry of hand and fingers, while CHESS-T1-SE often showed FS failure within the first metacarpal joint, tip of the finger, and ulnar aspect of the wrist joint. Overall image quality was significantly better with IDEAL than CHESS-T1-SE images (4.43 vs. 3.43, P < 0.01). Interobserver agreement (κ value) for synovitis and bone marrow contrast uptake was good to excellent with IDEAL (0.74-0.91, 0.62-0.89, respectively). IDEAL could compensate for the effects of field inhomogeneities, providing uniform FS of the hand and finger than did the CHESS-T1-SE sequence.

Weight loss is effective for symptomatic relief in obese subjects with knee osteoarthritis independently of joint damage severity assessed by high-field MRI and radiography

With an increasing prevalence of older and obese citizens, the problems of knee osteoarthritis (KOA) will escalate. Weight loss is recommended for obese KOA patients and in a majority of cases this leads to symptomatic relief. We hypothesized that pre-treatment structural status of the knee joint, assessed by radiographs, 1.5 T magnetic resonance imaging (MRI) and knee-joint alignment, may influence the symptomatic changes following a significant weight reduction. Patients were recruited from a Department of Rheumatology. Eligibility criteria were age above 50 years, body mass index ≥ 30 kg/m(2), primary KOA diagnosed according to the American College of Rheumatology (ACR) criteria and having verified structural damage. Patients underwent a 16 weeks dietary programme with formula products and counselling. MRI and radiographs of the most symptomatic knee were obtained at baseline and assessed for structural damage using the Boston-Leeds Osteoarthritis of the Knee Score, minimum joint space width and Kellgren-Lawrence score. Imaging variables, muscle strength and degree of alignment, were examined as predictors of changes in Knee Osteoarthritis Outcome Score (KOOS) and Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) - Osteoarthritis Research Society International (OARSI) Responder Criterion. Structural damage at baseline assessed by imaging, muscle strength or knee-joint alignment showed no statistically significant association to changes in KOOS pain and function in daily living (r ≤ 0.13; P>0.05) or the OMERACT-OARSI Responder Criterion (OR 0.48-1.68; P-values ≥ 0.13). Presence of joint damage did not preclude symptomatic relief following a clinically relevant weight loss in older obese patients with KOA. Neither muscle strength nor knee-joint alignment was associated with the degree of symptomatic relief.

High molecular weight hyaluronan for treatment of chronic shoulder pain associated with glenohumeral arthritis

BackgroundThere is insufficient evidence to determine whether intra-articular injections may be effective for treatment of glenohumeral osteoarthritis. Euflexxa® (high molecular weight hyaluronate), a bioengineered high molecular weight hyaluronan, has been shown to be a safe and effective treatment for patients with knee osteoarthritis. There is also support for the use of hyaluronate injection for the treatment of chronic shoulder pain associated with osteoarthritis or rotator cuff damage. This small-scale exploratory study was conducted to evaluate the safety and efficacy of high molecular weight hyaluronate for the treatment of chronic shoulder pain associated with osteoarthritis.MethodsSubjects with glenohumeral osteoarthritis and chronic pain (n = 27) received one injection per week for 3 weeks of high molecular weight hyaluronate and were assessed for changes in pain (100 mm visual analog scale [VAS]), range of motion, and the subject’s and physician’s global assessment over 26 weeks. Subjects were also assessed for pain, stiffness, and physical functioning using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Finally, responses were evaluated using modified Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-Osteoarthritis Research Society International (OARSI) Proposition D criteria. Safety was assessed by recording adverse events.ResultsHigh molecular weight hyaluronate significantly improved pain (VAS, WOMAC), range of motion, stiffness, and physical functioning scores; 77.8% of subjects were rated as having an OMERACT-OARSI Proposition D high response. There were no serious adverse events, and none were considered to be related to treatment.ConclusionTreatment with high molecular weight hyaluronate improves pain, stiffness, and range of motion, and may have an acceptable safety and tolerability profile. A randomized, double-blind, placebo-controlled clinical trial may be warranted to investigate further the efficacy and safety of intra-articular high molecular weight hyaluronate for treatment of chronic shoulder pain in patients with glenohumeral osteoarthritis.

Significance of anti-cyclic citrullinated peptide antibody and magnetic resonance imaging of metacarpophalangeal joints and wrist in early rheumatoid arthritis

To study the diagnostic value of anti-cyclic citrullinated peptide antibody (anti-CCP) and magnetic resonance imaging (MRI) of metacarpophalangeal joints (MCP) and wrist in early rheumatoid arthritis (RA). MRI of MCP and wrist joint, laboratory indices of anti-CCP and rheumatic factor (RF) were performed and recorded in the 94 early-stage RA patients, 24 non-typical monoarthritis and 35 other arthritis. The MRI findings and OMERACT (outcome measures in rheumatoid arthritis clinical trials) score were analyzed in comparison with their clinical and laboratory indices. The sensitivity of anti-CCP, synovitis, bone erosion and bone erosion was 55.3%, 100%, 25.5% and 88.3% respectively in early-stage RA patients. The specificity was 88.6%, 71.4%, 94.3% and 65.7% respectively. There was significant difference between early-stage RA group and other arthritis group (P < 0.05). Bone erosion was found to be the most specific among MRI findings. And bone erosion of wrist joint had a positive correlation with anti-CCP. MRI was a more efficient supplemental modality in diagnosing early-stage RA as compared with conventional radiological films. Among 94 early-stage RA, their MRI findings and OMERACT scores of wrist joint appeared more obvious. Anti-CCP has a better specificity for early-stage RA than RF. But MRI may visualize the disorder of RA earlier while it is often missed by radiological films. Both have prominent diagnostic values in early RA patients. Bone erosion of wrist joint has a positive correlation with anti-CCP. MRI may help to differentiate those RA patients with negative anti-CCP.

Magnetic Resonance Imaging of the Rheumatic Foot According to the RAMRIS System Is Reliable

In rheumatology, magnetic resonance imaging (MRI) is predominantly applied in the assessment and outcome measurement of rheumatoid arthritis (RA) in hands and wrists, leading to the development of the RAMRIS (RA-MRI-Scoring) system. It was initiated by the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). The RAMRIS system has not been applied widely in the measurement of feet. We investigated the interreader and intrareader agreement of the RAMRIS scoring system in the assessment of feet in RA. Twenty-nine patients with RA who had radiological damage and/or arthritis underwent MRI. Two experienced readers independently read both complete sets. One reader read 6 random sets after the initial session, in order to assess the intrareader agreement. For evaluation of the intrareader and interreader reliability, quadratic-weighted κ scores were calculated per joint and lesion. For the forefeet, interreader scores were excellent, ranging from 0.77 (bone edema) to 0.95 (bone erosion). Hindfoot interreader agreement scores were highest for erosion (0.90) and synovitis global score (0.88), but edema and synovial thickness agreement were also acceptable (0.83 and 0.86). Intrareader scores were on the whole slightly lower, but excellent. Reliability (interreader and intrareader agreement) in the assessment of the rheumatoid foot according to the RAMRIS method is excellent.

Assessment of hand bone loss in rheumatoid arthritis by high-resolution peripheral quantitative CT

ObjectivesA new high-resolution peripheral quantitative CT (HR-pQCT) system allows for in vivo assessment of bone microarchitecture and volumetric bone mineral density (vBMD) with an 82 µm isotropic resolution. With this...

Reliability of high-resolution ultrasonography in the assessment of Achilles tendon enthesopathy in seronegative spondyloarthropathies

Objective:The present study was mainly aimed at investigating the interobserver and intraobserver reproducibility of ultrasound (US) results in the assessment of Achilles tendon enthesopathy in patients with seronegative spondyloarthropathies (SpA).Methods:A...

Evaluation of several ultrasonography scoring systems for synovitis and comparison to clinical examination: results from a prospective multicentre study of rheumatoid arthritis

ObjectivesTo evaluate different global ultrasonographic (US) synovitis scoring systems as potential outcome measures of rheumatoid arthritis (RA) according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) filter.MethodsTo study...